Merit Medical Systems Recalls Vein Kits Due to Incorrect Latex Labeling
Merit Medical Systems is recalling 24 Vein Procedure Kits because they were incorrectly labeled as latex-free.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Moderate because it involves a minor labeling error regarding a common allergen (latex) without reported illnesses or injuries, fitting the criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Merit Medical Systems, Inc. is recalling 24 units of the Custom Procedure Kit, Vein Kit (Product Code/REF: K12T-10167). The recall was initiated due to a labeling error where the kits were identified as containing incorrect latex information, specifically indicating that the product was latex-free when it was not.
The affected kits are single-use, prescription-only, and sterile. The distribution pattern for these 24 kits was limited to the states of Virginia and Illinois. The specific lot number is K12T-10167, with a use-by date of November 5, 2018.
Consumers and healthcare facilities should check their inventory for this specific product code and lot number. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations, as the incorrect labeling poses a risk to patients with latex allergies.
The recalled product
- Product
- Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog # K12T-10167
- Lot # K12T-10167
- Use By: 2018-11-05
Distribution
Part of a larger recall action
This product is one of 2 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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